OncoMatch/Clinical Trials/NCT04678362
TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma
Is NCT04678362 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Talazoparib + Avelumab for urothelial carcinoma.
Treatment: Talazoparib + Avelumab — The main objectif is to determine the efficacy of a maintenance treatment combining Talazoparib and Avelumab after platinum-based chemotherapy in patients with locally advanced/metastatic urothelial carcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage IV, T4B, N0, M0, ANY T, N1-N3, M0, ANY T, ANY N, M1
Metastatic disease required
Documented Stage IV disease (T4b, N0, M0; any T, N1-N3, M0; any T, any N, M1) not candidate to a curative treatment with surgery or radiotherapy at the start of first-line platinum-based chemotherapy.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy (cisplatin, carboplatin) — first-line for advanced/metastatic disease
Patient must have completed prior to inclusion a platinum-based (cisplatin or carboplatin) polychemotherapy for at least 4 cycles of chemotherapy (until 6 cycles maximum) and have a stable disease or a partial response (PR) or a complete response (CR) from the chemotherapy according to RECIST 1.1 criteria
Cannot have received: PARP inhibitor
Any previous treatment with PARP inhibitor
Cannot have received: immunotherapy
Any previous treatment with ... any immunotherapy (e.g. anti-CTLA-4 or anti-PDL1/ PD1)
Cannot have received: chemotherapy
Patient who has previously received more than one line of chemotherapy for advanced/metastatic urothelial carcinoma
Lab requirements
Blood counts
Hemoglobin ≥ 10.0 g/dL (patient may have been transfused before inclusion); ANC ≥1.5 x 10^9/L; Platelet count ≥100 G/l
Kidney function
creatinine clearance estimated using the CKD equation of ≥ 40 mL/min
Liver function
Total bilirubin ≤1.5 x institutional ULN; AST/ALT ≤2.5 x ULN unless liver metastases are present in which case they must be ≤5x ULN
Normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below: Hemoglobin ≥ 10.0 g/dL ... Platelet count ≥100 G/l ... Total bilirubin ≤1.5 x institutional upper limit of normal (ULN) ... AST/ALT ≤2.5 x ULN unless liver metastases are present in which case they must be ≤5x ULN ... creatinine clearance estimated using the CKD equation of ≥ 40 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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